Skip to content

OPTIM 1 Wipes

by Dent4You AG

Ref OPTEU1-12W

OPTIM 1 Wipes (OPTEU1-12W) is a Class IIa device made by Dent4You AG, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 764018507OPTIM1KS), withdrawn as of 25 Oct 2026.

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764018507OPTIM1KS Basic UDI-DI 17640397420717UDI-DIDate26 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device name
Optim 1
Model / reference
OPTEU1-12W
Primary DI / UDI-DI
17640397420717
Basic UDI-DI
764018507OPTIM1KS
EMDN code
D0599 Oxygen producers for disinfection of medical devices - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000028926
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Similar devices in this category

Other devices filed under OXYGEN PRODUCERS FOR DISINFECTION OF MEDICAL DEVICES - OTHER.

Other devices from Dent4You AG

See all devices from Dent4You AG →

Properties

Other properties (14, all answered No)